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Randomized Multicenter Study on Pancreatic Duct Stenting in Disrupted or Obstructed Ducts in Context With Endoscopic Treatment of Pancreatic Pseudocysts.


N/A
18 Years
N/A
Open (Enrolling)
Both
Chronic Acute Pancreatitis

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Trial Information

Randomized Multicenter Study on Pancreatic Duct Stenting in Disrupted or Obstructed Ducts in Context With Endoscopic Treatment of Pancreatic Pseudocysts.


Inclusion Criteria:



- pancreatic pseudocyst, at least 6 cm in diameter

- symptomatic pancreatic pseudocyst

- increasing size of pancreatic pseudocyst within 6 weeks

Exclusion Criteria:

- Pregnancy

- Age less than 18 years

- Postoperative status preventing access to papilla

- Allergy to contrast preventing from ERP

- Missing informed consent to study

- PTT above 1.5 times of normal, unless substituted

- Platelet count less than 50.000/┬Ál, unless substituted

- Pancreatic ascites or fistula

- Life expectancy less than 2 years

- Percutaneously drained cysts are not part of the study

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recurrence of pancreatic pseudocyst

Outcome Description:

-

Outcome Time Frame:

two years

Safety Issue:

No

Principal Investigator

Mark Ellrichmann, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel, Germany

Authority:

Germany: Ethics Commission

Study ID:

UKSH-122010

NCT ID:

NCT01276002

Start Date:

January 2011

Completion Date:

June 2014

Related Keywords:

  • Chronic Acute Pancreatitis
  • disrupted duct
  • pancreatic pseudocysts
  • Pancreatic Pseudocyst
  • Pancreatitis

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